Senior specialist, quality assurance, on-the-floor

Senior Specialist, Quality Assurance, On-the-floor
Senior Specialist, Quality Assurance, On-the-floorApply locations Melbourne - Australia Quality time type Full time posted on Posted 4 Days Ago job requisition id R17454
The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.
As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.
As a Quality Assurance Associate, you will be responsible for real-time, on-the-floor quality oversight of internal manufacturing at Moderna.
This position ensures compliance with cGMP standards for the production of mRNA drug substances at our Melbourne facility.
You will collaborate closely with Operations, Manufacturing Science and Technology, and other teams to ensure operational excellence while maintaining strict adherence to Moderna's Quality System.
This is a shift-based, individual contributor role requiring strong decision-making skills and an ability to escalate critical issues when necessary.
Here's What You'll Do Your key responsibilities will be: Providing on-the-floor Quality support to Manufacturing, including real-time observation of activities to ensure compliance.Monitoring process operations to ensure adherence to specifications.Scheduling and allocating work resources for effective quality oversight.Making critical quality decisions and escalating issues to management when needed.Performing routine walkthroughs of manufacturing suites to ensure GMP compliance and best practices.Your responsibilities will also include: Enforcing adherence to cGMPs, SOPs, and documentation for all manufacturing operations.Maintaining expertise in Quality Systems, including deviations, CAPAs, and change controls.Triaging and reviewing minor deviations while working with cross-functional teams.Reviewing executed batch records (both electronic and paper) to ensure regulatory compliance.Practicing safe work habits and ensuring adherence to safety protocols.Supporting a shift structure to ensure continuous oversight of manufacturing operations.Contributing to process improvements to enhance operational efficiency.The key Moderna Mindsets you'll need to succeed in the role: We act with urgency – In this role, real-time quality oversight is critical.
Your ability to swiftly assess situations, identify risks, and escalate concerns when necessary will directly impact the success of Moderna's manufacturing operations.We obsess over learning – The dynamic nature of mRNA manufacturing and GMP compliance requires continuous learning.
You will be expected to stay ahead of evolving quality standards, adapt to new data, and improve processes based on real-time observations.Here's What You'll Need (Basic Qualifications) Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent combination of education and experienceMinimum 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing PracticesKnowledge and use of electronic systems, including SAP, LIMS, and MODA, for batch release, deviations, lab data management, and manufacturing execution.This position is site-based, requiring you to be at Moderna's site full-time.
This position is not eligible for remote work.Here's What You'll Bring to the Table (Preferred Qualifications) A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

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